- Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials.
- Coordinates patient care in compliance with protocol requirements. May disburse investigational drug. Maintains investigational drug accountability. Oversees the preparation of orders by physicians to assure that protocol compliance is maintained. Packages and ships lab specimens to central vendors where applicable. Required to complete Hazmat and/or IATA training.
- In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings and participates in data collection of all subjects.
- Responsible for preparing study-related documentation such as protocol worksheets, adverse event reports, institutional review board documents, and annual continuing review reports.
- Maintains regulatory documents in accordance with USOR SOP and applicable regulations. May participate in scheduling monitoring and auditing visits, as well as interact with the monitors/auditors while onsite. May collaborate with Research Site Leader in the study selection process.
- Participates in required training and education programs. May be responsible for education of clinic staff regarding clinical research. Collaborates with staff in the development of action plans and performance improvement opportunities with staff to improve quality.
- May be responsible for compiling and reporting protocol activity, accrual trends, data entry compliance, and research financial information to practice administration and physicians. May be responsible for reviewing protocol specific billing guides and submitting billing information to appropriate personnel.
- Other duties may be assigned as needed to meet company goals.
- Minimum three years of experience in a clinical or scientific related discipline required, preferably in oncology.
- SoCRA or ACRP certification preferred.
- Experience working with physicians preferred
- Experience working in clinical research is preferred
- Excellent organizational skills
- Strong ability to multi-task
- Excellent time management skills
- Must have strong interpersonal skills to be able to interact with multiple people on many different levels
- Must have a high level of attention to detail
- Must be able to work in a fast-paced environment
- May be responsible for basic clinical assessments
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University of Maryland College Park, United States**Posting Details**: · - Posting Details**Position Number**: · **Title**: · - Coordinator**Functional Title**: · - Research Coordinator**Category Status**: · - 33-Exempt Regular**Applicant Search Category**: · - Staff**University Authorized FTE**: · - 1.000**Unit**: · - CMNS-Eart ...
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Cape Fox Corporation Rockville, United StatesShare this job as a link in your status update to LinkedIn. · Job Title · Clinical Research Coordinator, · Job Description · Concentric Methods is seeking a Clinical Research Coordinator to join our team in Rockville, MD in support of the NIH. · Responsibilities: · Supports clini ...
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Children's National Hospital Rockville, United StatesThe Clinical Research Coordinator participates in or leads day-to-day operations of clinical research studies conducted by a principal investigator. The Research Coordinator performs a variety of duties involved in the collection, compilation, documentation and analysis of clinic ...
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Sunstone Therapies Rockville, United StatesJob Description · Job DescriptionScope: We are seeking a highly skilled and motivated Clinical Research Coordinator who is also a certified Registered Nurse (RN) to join our team in Rockville, MD. The successful candidate will be responsible for coordinating and overseeing clinic ...
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Children's National Rockville, United States Full timeClinical Research Coordinator Description The Clinical Research Coordinator participates in or leads day-to-day operations of clinical research studies conducted by a principal investigator. The Research Coordinator performs a variety of duties involved in the collection, compila ...
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Guidehouse Bethesda, United StatesJob Family: · Patient Care Coordinator (Digital) · Travel Required: · None · Clearance Required: · Ability to Obtain Public Trust · What You Will Do: · We are currently searching for a Clinical Research Coordinator to provide clinical research coordination and protocol navigation ...
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Henry M. Jackson Foundation Bethesda, United StatesOverview · Join the HJF Team · HJF is seeking a Research Coordinator II to support research studies focused on pain at the Uniformed Services University (USU) and Walter Reed National Military Center (WRNMMC). · This position will be in support of the Defense & Veterans Center fo ...
Clinical Research Coordinator II - Rockville, United States - US Oncology
Description
OverviewAre you looking for a Great place to work? Our team at Maryland Oncology Hematology is looking for ""star"" talent.
If you believe you have what it takes to create a rewarding experience for our Physicians, patients, and team members, we would enjoy the opportunity to speak with youMaryland Oncology Hematology is dedicated to providing the most advanced cancer care available anywhere in an atmosphere of caring compassion.
We have over 15 convenient locations throughout Maryland and in DC.Job Summary:
Responsible for recruiting, screening, consenting, and enrolling patient in clinical trials. CRC II also coordinates and oversees the subject's visits in accordance with the protocol requirements.
Duties include but not limited to assuring protocol compliance for all patients enrolled in the trial, participation in the informed consent process, perform ongoing assessments and documentation in collaboration with physicians and other providers.
Acts as resource for the education and training of clinic staff as well as resource for problem solving of complex issues for the implementation of the research process throughout the clinic, process improvements and SOPs.
Compiles and reports protocol activity; accrual data, and financial information. Assures site research quality by practicing in compliance with US Oncology Research, Inc.(USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA.
Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.Responsibilities
Key Responsibilities
Minimum Job Qualifications (Knowledge, Skills, & Abilities):
Education/Training -* Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred.
Working Conditions:
Environment (Office, warehouse, etc.) -* Traditional office environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to anoncology/hematology clinic environment.
Physical Requirements (Lifting, standing, etc.) -* Large percent of time performing computer based work is required
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.#J-18808-Ljbffr
